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Vaccination Response in ImmunoCompromised Host. Immune Response After Vaccination Against Pandemic A/H1N1 Influenza

NCT01066169 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 104

Last updated 2012-01-30

No results posted yet for this study

Summary

As recommended by the Dutch Health Council, certain risk groups and health care workers in The Netherlands were vaccinated to prevent morbidity due to pandemic influenza A/H1N1. Adults were vaccinated twice with the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted surface-antigen vaccine Focetria® (Novartis). The vaccination campaign was executed by general practitioners.

The aim of the study is to verify whether HIV-infected individuals generate an adequate immune response after the first and after the second vaccination.

Conditions

Interventions

BIOLOGICAL

Foceteria® (Novartis)

This is not an interventional study. In this observational study we monitored the immune response in a cohort of people who were vaccinated during the national vaccination campaign. The vaccine that was used in The Netherlands is the monovalent influenza A/California/2009(H1N1) MF59-adjuvanted surface-antigen vaccine. It contains 7,5 µg hemagglutinine and the MF59C.1 adjuvant, which is an oil-in-water emulsion, composed of Squalene 9.75 mg, Polysorbate 80 1.175 mg and Sorbitan trioleate 1.175 mg. This vaccine has been approved for use according to a two dose schedule.

Sponsors & Collaborators

Principal Investigators

  • Frank P Kroon, MD PhD · Leiden University Medical Centre

  • Leo G Visser, MD PhD · Leiden University Medical Centre

  • Luc BS Gelinck, MD · Leiden University Medical Centre

  • A F Rimmelzwaan, Prof PhD · Leiden University Medical Centre

  • Darius Soonawala, MD · Leiden University Medical Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01066169 on ClinicalTrials.gov